Endoscope attachment mechanism for use with suture based closure device

ABSTRACT

A suture assembly includes a translation assembly that is axially translatable within a working channel of an endoscope and is adapted to releasably secure and/or release a needle and a distal end cap that is securable to an end of the endoscope and is adapted to releasably secure and/or release the needle in order to pass the needle back and forth between the translation assembly and the distal cap. An attachment mechanism configured to releasably secure the distal endcap to an end of the endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 ofU.S. Provisional Application No. 62/848,995 filed May 16, 2019 and U.S.Provisional Application No. 62/690,637, filed Jun. 27, 2018, the entiredisclosures of which are hereby incorporated by reference.

TECHNICAL FIELD

The disclosure is directed to devices for suturing tissue and moreparticularly to devices that work with an endoscope or similar devicefor endoscopically suturing tissue.

BACKGROUND

A variety of endoscopic treatments may result in defects (or wounds)that are too large for known closure methods. Examples of suchendoscopic treatments include removal of large lesions, tunneling underthe mucosal layer, full thickness removal of tissue, treating otherorgans by passing outside of the gastrointestinal tract, andpost-surgical repair of post-surgical leaks. Endoscopic treatments alsoinclude bariatric revision procedures. Of the known devices and methodsfor endoscopically closing large defects, each has certain advantagesand disadvantages.

SUMMARY

The disclosure is directed to several alternative designs, materials andmethods of devices for endoscopically closing large defects. An exampleis a suture assembly for use in combination with an endoscope having aworking channel and a distal end. The suture assembly includes atranslation assembly that is axially translatable within the workingchannel and that includes a needle configured to carry a suture, adistal shuttle configured to releasably secure the needle and a sleevethat is disposable over the distal shuttle. The sleeve is movablebetween a locked position in which the needle is secured to the distalshuttle and an unlocked position in which the needle is releasable fromthe distal shuttle. A distal endcap is securable to the distal end ofthe endoscope and is configured to engage the needle when the needle isadvanced distally into the endcap and to release the needle when theneedle is locked to the distal shuttle and the distal shuttle iswithdrawn proximally. An attachment mechanism is disposable over anexterior of the endoscope proximate the distal end thereof and isconfigured to releasably secure the distal endcap relative to the distalend of the endoscope.

Alternatively or additionally, the attachment mechanism may include aninner collet member that is configured to engage the distal endcap andform a compressive fit with the endoscope and an outer collet memberthat is configured to engage the inner collet member in order to formthe compressive fit between the inner collet member and the endoscope.

Alternatively or additionally, the distal endcap may further include anannular flange disposed at a proximal end of the distal endcap, and theinner collet member may further include a corresponding annular slotdisposed near a distal end of the inner collet member, the annular slotconfigured to engage the annular flange, thereby providing aninterference fit between the distal endcap and the inner collet member.

Alternatively or additionally, the inner collet member may include anbody having a plurality of fingers extending axially in a proximaldirection from the distal end of the inner collet member, the pluralityof fingers defining an inner surface that is configured to engage theendoscope and an outer surface that provides threads to threadedlyengage the outer collet adaptor.

Alternatively or additionally, the outer collet member may be configuredto urge the plurality of fingers inwardly as the outer collet member isadvanced over the inner collet member.

Alternatively or additionally, the attachment mechanism may include asplit ring attachment mechanism disposable over an exterior of theendoscope proximate the distal end thereof, the split ring attachmentmechanism including an endoscope engaging portion adapted to engage theendoscope in a compressive fit and a distal endcap engaging portionadapted to engage the distal endcap in an interference fit.

Alternatively or additionally, the split ring attachment mechanism mayinclude an elongate body having an inner surface that is adapted to fitover an exterior surface of the endoscope and a living hinge extendinglongitudinally along the elongate body. The elongate body includes afirst body portion extending circumferentially in a first direction fromthe living hinge and a second body portion extending circumferentiallyin a second direction from the living hinge.

Alternatively or additionally, once the elongate body has been advancedradially over the endoscope and the distal end cap, the elongate bodymay be configured to be held in a locking configuration in which thedistal endcap is secured to the distal end of the endoscope via one ormore members that extend at least partially radially around the elongatebody.

Alternatively or additionally, the distal endcap may further include anannular flange disposed at a proximal end of the distal endcap, and thesplit ring attachment mechanism may further include a correspondingannular slot configured to engage the annular flange, thereby providingan interference fit between the distal endcap and the split ringattachment mechanism.

Alternatively or additionally, the inner collet member may be integrallyformed with the distal endcap.

Alternatively or additionally, the inner collet member may include aplurality of fingers extending proximally from the distal endcap, andthe outer collet member may include a ring that is configured to bemoved proximally over the plurality of fingers, thereby pressing theplurality of fingers into a compressive fit with the endoscope.

Alternatively or additionally, the attachment mechanism may include afixation member extending from the distal endcap and an elastomericsleeve configured to form a compressive fit with the endoscope, theelastomer sleeve including a fixation aperture that is complementary tothe fixation member.

Another example is a suture assembly for use in combination with anendoscope having a working channel and a distal end. The suture assemblyincludes a translation assembly that is axially translatable within theworking channel and is adapted to releasably engage and disengage aneedle. A distal endcap is securable to the distal end of the endoscopeand is adapted to releasable engage the needle when the translationassembly disengages the needle and to disengage the needle when thetranslation assembly engages the needle, the distal endcap including afixation flange disposed near a proximal end of the distal endcap. Aninner collet member is configured to engage the distal endcap and form acompressive fit with the endoscope and an outer collet member isconfigured to engage the inner collet member in order to form thecompressive fit between the inner collet member and the endoscope.

Alternatively or additionally, the outer collet member may be threadedlyengageable with the inner collet member in order to form the compressivefit with the endoscope.

Alternatively or additionally, the distal endcap may further include anannular flange disposed at a proximal end of the distal endcap, and theinner collet member may further include a corresponding annular slotdisposed near a distal end of the inner collet member, the annular slotconfigured to engage the annular flange, thereby providing aninterference fit between the distal endcap and the inner collet member.

Alternatively or additionally, the inner collet member may include anbody having a plurality of fingers extending axially in a proximaldirection from the distal end of the inner collet member, the pluralityof fingers defining an inner surface that is configured to engage theendoscope and an outer surface that provides threads to threadedlyengage the outer collet adaptor.

Alternatively or additionally, the outer collet member may be configuredto urge the plurality of fingers inwardly as the outer collet member isadvanced over the inner collet member.

Another example is a suture assembly for use in combination with anendoscope having a working channel and a distal end. The suture assemblyincludes a translation assembly that is axially translatable within theworking channel and is adapted to releasably engage and disengage aneedle. A distal endcap is securable to the distal end of the endoscopeand is adapted to releasable engage the needle when the translationassembly disengages the needle and to disengage the needle when thetranslation assembly engages the needle, the distal endcap including afixation flange disposed near a proximal end of the distal endcap. Asplit ring device is disposable over an exterior of the endoscopeproximate the distal end thereof, the split ring device including acylindrical inner surface adapted to frictionally engage an outersurface of the endoscope and an annular slot adapted to engage thefixation flange in an interference fit.

Alternatively or additionally, the split ring device may include aninner surface that is adapted to fit over an exterior surface of theendoscope.

Alternatively or additionally, the split ring device may include aliving hinge that divides the split ring device into a first clampingportion extending circumferentially in a first direction from the livinghinge and a second clamping portion extending circumferentially in asecond direction from the living hinge.

Alternatively or additionally, the split ring device may be movablebetween a locking configuration in which the first clamping portion andthe second clamping portion frictionally engage an outer surface of theendoscope and an engagement configuration in which the first clampingportion and the second clamping portion are deflected away from thelocking configuration.

Alternatively or additionally, the split ring device may further includea first hook extending from the first clamping portion and a second hookextending from the second body clamping portion.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present disclosure.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE FIGURES

The disclosure may be more completely understood in consideration of thefollowing description of in connection with the accompanying drawings,in which:

FIG. 1 is a perspective view of an illustrative suture device inaccordance with an example of the disclosure;

FIG. 2 is a perspective view of a distal assembly forming part of theillustrative suture device of FIG. 1, shown in an extended position;

FIG. 3 is a perspective view of the distal assembly of FIG. 2, shown ina retracted position;

FIG. 4 is a cross-sectional view of the distal assembly of FIG. 2, takenalong the line 4-4;

FIG. 5 is an exploded view of a portion of a suture translation assemblyforming part of the illustrative suture device of FIG. 1;

FIG. 6 is a side view of a distal shuttle and a member forming part ofthe suture translation assembly, with the member shown extended in alocked position;

FIG. 7 is a side view of the distal shuttle and the member of FIG. 6,with the member shown retracted in an unlocked position;

FIG. 8 is a side view of a distal assembly usable in the suture deviceof FIG. 1 in accordance with an example of the disclosure;

FIG. 9 is a side view of the distal assembly of FIG. 8 in combinationwith an attached flexible lumen;

FIG. 10 is a side view of a distal assembly usable in the suture deviceof FIG. 1, shown with an attached lumen, in accordance with an exampleof the disclosure;

FIGS. 11 and 12 are views of a tissue release mechanism that may be usedin combination with the distal assemblies of FIGS. 1 and 8 in accordancewith an example of the disclosure;

FIG. 13 is a perspective view of a distal assembly usable in the suturedevice of FIG. 1 in accordance with an example of the disclosure;

FIG. 14 is a perspective view of a suture translation assembly usable inthe suture device of FIG. 1 in accordance with an example of thedisclosure;

FIG. 15 is a partially exploded perspective view of the suturetranslation assembly of FIG. 14 in accordance with an example of thedisclosure;

FIG. 16 is a perspective view of an inner member forming a portion ofthe suture translation assembly of FIG. 14 in accordance with an exampleof the disclosure:

FIG. 17 is a perspective view of a portion of the suture translationassembly of FIG. 14, shown in a locked configuration in accordance withan example of the disclosure;

FIG. 18 is a perspective view of a portion of the suture translationassembly of FIG. 14, shown in an unlocked configuration in accordancewith an example of the disclosure;

FIG. 19 is a perspective view of a suture translation assembly usable inthe suture device of FIG. 1 in accordance with an example of thedisclosure;

FIG. 20 is a perspective view of the suture translation assembly of FIG.19, shown with some elements removed to show internal structure, withthe suture translation assembly shown in a locked configuration inaccordance with an example of the disclosure;

FIG. 21 is a side view of a portion of the suture translation assemblyof FIG. 19, showing how a locking member engages an inner member of thesuture translation assembly and a needle in the locked configuration asshown in FIG. 20 and in accordance with an example of the disclosure;

FIG. 22 is a perspective view of the suture translation assembly of FIG.19, shown in an unlocked configuration in accordance with an example ofthe disclosure;

FIG. 23 is a perspective view of a sleeve usable as part of a suturetranslation assembly;

FIG. 24 is a perspective view of a distal assembly utilizing the sleeveof FIG. 23 and usable in the suture device of FIG. 1 in accordance withan example of the disclosure;

FIG. 25 is a perspective view of a distal assembly in combination with asplit ring attachment mechanism in accordance with an example of thedisclosure;

FIG. 26 is a cross-sectional view of the distal assembly in combinationwith the split ring attachment mechanism of FIG. 25, taken along line26-26;

FIG. 27 is a perspective view of the split ring attachment mechanism ofFIG. 25;

FIG. 28 is a cross-sectional view of the split ring attachment mechanismof FIG. 27, taken along line 28-28 and showing the split ring attachmentmechanism in a locking configuration;

FIG. 29 is a cross-sectional view of the split ring attachment mechanismof FIG. 27, showing the split ring attachment mechanism in an engagementconfiguration;

FIG. 30 is a perspective view of the distal assembly and split ringattachment mechanism of FIG. 25 shown secured on an endoscope inaccordance with an example of the disclosure;

FIG. 31 is a perspective view of a split ring attachment mechanism inaccordance with an example of the disclosure;

FIG. 32 is a perspective view of a split ring attachment mechanism inaccordance with an example of the disclosure;

FIG. 33 is a cross-sectional view of the split ring attachment mechanismof FIG. 32, taken along line 33-33;

FIG. 34 is a perspective view of an inner collet member that may be usedas part of an attachment mechanism in accordance with an example of thedisclosure;

FIG. 35 is a perspective view of an outer collet member that may be usedin combination with the inner collet member of FIG. 34 in accordancewith an example of the disclosure;

FIGS. 36 and 37 are schematic cross-sectional views of the inner colletmember of FIG. 34 in accordance with an example of the disclosure;

FIG. 38 is a side view of the inner collet member of FIG. 34 and theouter collet member of FIG. 35 positioned on an endoscope preparatory tosecuring a distal endcap to the endoscope in accordance with an exampleof the disclosure;

FIG. 39 is a side view of the inner collet member of FIG. 34 and theouter collet member of FIG. 35 in position having secured the distalendcap to the endoscope in accordance with an example of the disclosure;

FIG. 40 is a side view of an attachment mechanism for securing a distalendcap to an endoscope in accordance with an example of the disclosure;

FIG. 41 is a side view of an attachment mechanism for securing a distalendcap to an endoscope in accordance with an example of the disclosure;

FIG. 42 shows the attachment mechanism of FIG. 41 having secured thedistal endcap to the endoscope in accordance with an example of thedisclosure;

FIG. 43 is a perspective view of an attachment mechanism in accordancewith an example of the disclosure;

FIG. 44 is a perspective view of an attachment mechanism and distalendcap in accordance with an example of the disclosure;

FIG. 45 is a perspective view of an attachment mechanism and distalendcap in accordance with an example of the disclosure;

FIGS. 46 and 47 are side views of an attachment mechanism and distalendcap in accordance with an example of the disclosure;

FIG. 48 is a side view of an attachment mechanism and distal endcap inaccordance with an example of the disclosure;

FIG. 49 is a side view of an attachment mechanism and distal endcap inaccordance with an example of the disclosure;

FIG. 50 is a side view of an attachment mechanism in accordance with anexample of the disclosure;

FIG. 51 is a side view of an attachment mechanism in accordance with anexample of the disclosure;

FIG. 52 is a side view of an attachment mechanism and distal endcap inaccordance with an example of the disclosure;

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

Definitions of certain terms are provided below and shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the term “about” may be indicative asincluding numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

Although some suitable dimensions, ranges and/or values pertaining tovarious components, features and/or specifications are disclosed, one ofskill in the art, incited by the present disclosure, would understanddesired dimensions, ranges and/or values may deviate from thoseexpressly disclosed.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include or otherwise refer to singular aswell as plural referents, unless the content clearly dictates otherwise.As used in this specification and the appended claims, the term “or” isgenerally employed to include “and/or,” unless the content clearlydictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The detailed description and the drawings, which are notnecessarily to scale, depict illustrative embodiments and are notintended to limit the scope of the disclosure. The illustrativeembodiments depicted are intended only as exemplary. Selected featuresof any illustrative embodiment may be incorporated into an additionalembodiment unless clearly stated to the contrary.

The disclosure pertains to devices that are configured to be used incombination with an endoscope or a similar delivery device for closingwounds within the body. In some instances, the suture devices describedherein may be configured such that they may be used within a singleworking or available channel of an endoscope, and in some embodimentsmay be operated by a single individual, although in some embodiments asecond individual may be involved. In some embodiments, the suturedevices described herein may be considered as operating along a singleline of operation. The device itself may be translatable distally andproximally within a working channel, and a handle portion may itself betranslatable distally and proximally along the same line of operation inlocking and unlocking a needle to be able to pass the needle back andforth between an active portion of the suture device and a passiveportion of the suture device. The device may be configured to enable theneedle to be selectively locked into either of a more distal position ora more proximal position, and the device may itself be translateddistally or proximally with the needle locked in place in order to movethe needle, and hence a suture, relative to the tissue being repaired.

FIG. 1 is a perspective view of a suture device 10 that may beconsidered as being configured for use in combination with a deliverysystem including a lumen that extends through the delivery system. Forexample, the delivery system may be an endoscope having a workingchannel. The delivery system may also be a catheter. It will beappreciated that there is a change in scale on either side of the breakline shown. In some embodiments, the suture device 10 may be consideredas including a suture translation assembly 12 that is configured to beaxially translatable within the lumen of the delivery system and adistal assembly 14 that is configured to be secured to a distal end ofthe delivery system. The suture translation assembly 12 extends into thedistal assembly 14 and includes a needle 16 that may be used to carry asuture as well as a distal shuttle 18 that is configured to releasablysecure the needle 16.

A member 20 may be disposed over the distal shuttle 18 and, as will beshown in subsequent Figures, is movable between a locked position inwhich the needle 16 is secured to the distal shuttle 18 and an unlockedposition in which the needle 16 is releasable from the distal shuttle18. In some embodiments, for example, the member 20 may be a sleeve 20.A user interface may extend proximally from the distal shuttle 18 andthe sleeve 20, and may be configured to move the sleeve 20 between thelocked position and the unlocked position. A shaft 28 may extenddistally to the suture translation assembly 12, and may in particular becoupled to the sleeve 20. The user interface may take a number ofdifferent forms. For examples, the user interface may be the userinterface 22 as described and illustrated in U.S. Patent ApplicationPublication No. 2018/0235604, which publication is incorporated byreference herein in its entirety. In some embodiments, the userinterface may be as described in a provisional application Ser. No.62/794,075 filed Jan. 18, 2019 and entitled ENDOSCOPIC SUTURING CONTROLHANDLE, which application is incorporated by reference herein in itsentirety. In some instances, the user interface may be as described in aprovisional application filed on the even date herewith, 62/848,853entitled CONTROL HANDLE FOR ENDOSCOPIC SUTURING, which application isincorporated by reference herein in its entirety. These are justexamples.

In some embodiments, the distal assembly 14 includes a body 29 having aproximal connector 30 that may be configured to be coupled to the distalend of an endoscope or other delivery system. In some embodiments, asillustrated, the proximal connector 30 may include a fixation feature401. As will be discussed with respect to subsequent Figures, thefixation feature 401, which may in some embodiments be considered asbeing a fixation flange 401, helps to secure the distal assembly 14 tothe distal end of an endoscope or other delivery system using a splitring attachment mechanism.

The body 29 includes an arm 32 that extends to an endcap 34. As will bediscussed, the endcap 34 may be configured to releasably engage anddisengage the needle 16. In some embodiments, for example, the endcap 34may be configured to engage the needle 16 when the needle 16 is advanceddistally into the endcap 34, and to release the needle 16 when theneedle 16 is locked into the distal shuttle 18 (as will be discussed)and the distal shuttle 18 is withdrawn proximally. The distal assembly14 may be considered as including a guide member 36 that may be securedto or integrally formed with the body 29, and may permit the suturetranslation assembly 12 to extend through the guide member 36 and totranslate relative to the guide member 36. In some embodiments, the body29 may include an aperture 27 that may enable other devices to beinserted through the aperture 27. In some instances, as will bediscussed with respect to subsequent Figures, the aperture 27 may beconfigured to accommodate a side-saddled lumen attachment element. Insome embodiments, the aperture 27 may include one or more of a pinaperture 31 a and a pin aperture 31 b that may, for example, be used tomount the aforementioned side-saddled lumen attachment element, orpossibly other features as well.

FIG. 2 and FIG. 3 show the suture translation assembly 12 extendedthrough the guide member 36 and into the distal assembly 14. In FIG. 2,the suture translation assembly 12 is shown in an extended position inwhich the needle 16 extends into the endcap 34 while in FIG. 3, thesuture translation assembly 12 is shown in a retracted position in whichthe needle 16 has been withdrawn proximally from the endcap 34. In someembodiments, as can be seen, the endcap 34 includes a proximal needleopening 37 that is configured to help guide the needle 16 into theproximal needle opening 37 as well as to accommodate the needle 16 whenthe needle 16 is advanced distally into the endcap 34. In someembodiments, the proximal needle opening 37 may extend all the waythrough the endcap 34 while in other cases the proximal needle opening37 may not pass all the way through the endcap 34. In some instances, asshown, the proximal needle opening 37 may be considered as being alignedwith a longitudinal axis 38 of the needle 16 (as shown in FIG. 3).

One or more securement openings 40 may be arranged orthogonal to theproximal needle opening 37 and one or more securements 42 that areconfigured to be disposed within the one or more securement openings 40,and which are configured to releasably engage the distal detent (as willbe discussed) of the needle 16. In some embodiments, there may be a pairof securement openings 40, one on either side of the endcap 34. In someembodiments, there may be a pair of securements 42, with one disposedwithin each of the pair of securement openings 40. In some embodiments,while shown schematically, the one or more securements 42 may be springsor coils, for example.

FIG. 4 is a cross-sectional view of the distal assembly 14, with thesuture translation assembly 12 disposed within the distal assembly 14.FIG. 5 is an exploded view of the suture translation assembly 12. Theneedle 16 may be considered as including a distal region 44 and aproximal region 46. In some embodiments, the distal region 44 mayinclude a distal detent 48 for releasably engaging the endcap 34 and theproximal region 46 may include a proximal detent 50 for releasablyengaging the distal shuttle 18. The needle 16 may, as shown, include anaperture 52 for accommodating a suture line passing therethrough.

In some embodiments, the distal shuttle 18 may be considered asincluding a distal needle opening 54 that is configured to accommodatethe needle 16 when the distal shuttle 18 is advanced distally over theneedle 16 and that is aligned with the longitudinal axis 38 of theneedle 16. One or more bearing ball openings 56 may be arrangedorthogonal to the distal needle opening 54 such that the one or morebearing ball openings 56 align with the proximal detent 50 when theneedle 16 is secured to the distal shuttle 18. In some embodiments, oneor more bearing balls 58 may be disposed within the one or more bearingball openings 56 and may be configured to be disposed within theproximal detent 50 when the needle is secured to the distal shuttle 18.

In some embodiments, the distal shuttle 18 includes an internal void 60and a sleeve capture member 62 that is slidingly disposed within theinternal void 60. In some embodiments, the sleeve capture member 62 maybe coupled to a cable 64 extending distally within the shaft 28 and intoa cable aperture 66 and secured via a crimp or other mechanicalconnection 68. In some embodiments, the sleeve capture member 62 may becoupled to the sleeve 20 via a pin 70 that extends through first andsecond sleeve connection apertures 72, 74 and a corresponding aperture76 extending through the sleeve capture member 62 as well as extendingthrough the internal void 60.

In some embodiments, the sleeve 20 includes one or more sleeve openings80 that may be smaller in diameter, or smaller in width, than thediameter of the one or more bearing balls 58. In some embodiments, thesleeve 20 may include a pair of sleeve openings 80, corresponding to apair of bearing ball openings 56 and a pair of bearing balls 58. Whenthe sleeve 20 is in the locked position, as shown for example in FIG. 6,the one or more sleeve openings 80 are misaligned with, or do not alignwith, the one or more bearing ball openings 56, and so the one or morebearing balls 58 engage the proximal detent 50 of the needle 16. Thesleeve 20 prevents the one or more bearing balls 58 from being pushedout of the proximal detent 50.

Conversely, when the sleeve 20 is in the unlocked position, as shown forexample in FIG. 7, the one or more sleeve openings 80 are aligned withthe one or more bearing ball openings 56. This permits the one or morebearing balls 58 to move radially out, into the one or more sleeveopenings 80, a distance sufficient to permit the one or more bearingballs 58 to clear the proximal detent 50 of the needle 16 in response toa force applied to the one or more bearing balls 58 by the needle 16.With reference to FIG. 4, while the suture translation assembly 12 isshown advanced into the distal assembly 14, the sleeve 20 is in theunlocked position relative to the distal shuttle 18, and thus the one ormore bearing balls 58 may be seen as extending partially into the one ormore sleeve openings 80.

In some embodiments, it will be appreciated that the distal shuttle 18,and the sleeve 20, in combination, provide an active connection to theneedle 16 while the distal endcap 34 provides a passive connection tothe needle 16. If the needle 16 is moved distally into the distal endcap34, the distal endcap 34 will grab onto the needle 16, with the one ormore securements 42 engaging the distal detent 48. If the needle 16 issubsequently moved proximally, the axial force applied overcomes anyresistance provided by the one or more securements 42, and the needle 16is able to release from the distal endcap 34 and move proximally. Incontrast, the active connection to the needle 16 provided by the distalshuttle 18 and the sleeve 20, however, requires action to move thesleeve 20, relative to the distal shuttle 18, between the lockedposition and the unlocked position. The user interface provides amechanism for positively moving the sleeve 20 between the locked andunlocked positions.

FIG. 8 is a side view of a distal assembly 14 a that may, for example,be usable in the suture device 10 shown in FIG. 1. The distal assembly14 a is similar to the distal assembly 14 shown in previous Figures, butincludes a side-saddled lumen attachment element 120 that is coupled tothe body 29 of the distal assembly 14 a. In some embodiments, theside-saddled lumen attachment element 120 may include one or two pegs122 that fit into the pin apertures 31 a and 31 b (pin aperture 31 a isvisible in this view) and thus enable the side-saddled lumen attachmentelement 120 to pivot relative to the body 29 of the distal assembly 14a. In some embodiments, the side-saddled lumen attachment element 120includes a ring 124, from which the pegs 122 extend, a distal region 126and a body 128 that in some instances has a curvature to it.

In some embodiments, the distal region 126 and the body 128 have asemi-circular profile in order to accommodate a lumen such as a flexiblelumen 130 that may engage within the side-saddled lumen attachmentelement 120 via a frictional or compressive fit as shown in FIG. 9. Theflexible lumen 130 may be polymeric or metallic. A polymeric lumen may,for example, be expanded to a full working dimension by extending amandrel through the flexible lumen 130 after the flexible lumen 130 hasbeen placed relative to the side-saddled lumen attachment element 120.

In some embodiments, the side-saddled attachment element 120 (andaccompanying flexible lumen 130) may be used as a secondary workingchannel and may contain the suture used in the procedure. In someembodiments, it may be large enough to accommodate secondary tools foruse during the procedure for tissue acquisition or manipulation allowingsecondary tool use without requiring a dedicated dual-channel deliverysystem such as a dual channel endoscope. If desired, a dual-channeldelivery system could be used to provide even more options in aprocedure. The side-saddled attachment element 120 may have an exit portin the distal assembly 14 a such that secondary tools extend along anaxis suitable for tissue manipulation. This axis may cross the axis ofthe suture carrying element, allowing a secondary tool to pull tissueinto the suture carrying element's projected path. For example, thiscould be used to pull tissue in line with a needle to assist in drivingthe needle 16 through the tissue. Maintaining tension on the suturethrough the side-saddled attachment element 120 may keep the suture frominterfering with the procedure.

FIG. 10 is a perspective view of a distal assembly 14 b that includes ashorter side-saddled lumen attachment element 120 a that may bepivotally secured to the body 29 via one or more pegs 122 a that extendinto the pin apertures 31 a, 31 b. A lumen 130 a coupled with theside-saddled lumen attachment element 120 a to provide a working channelthrough which the suture or other tools may be extended.

FIG. 11 and FIG. 12 are views of a tissue release mechanism 150 that mayfit over the arm 32. In some embodiments, the tissue release mechanism150 may assist in a procedure by helping to remove tissue that mayotherwise become stuck on the needle 16. In some instances, the tissuerelease mechanism 150 may be spring-loaded to engage the needle 16, ormay be separately and independently actuated. In some instances, thetissue release mechanism 150 includes a cross-bar 152 that provides anadditional surface that can push tissue off of the needle 16.

In preparing the suture device 10 for use, the distal assembly 14 may besecured to a delivery device such as an endoscope. In some embodiments,an attachment enabler, such as a flexible silicone tube, may be unrolledalong the delivery device in order to hold the distal assembly 14 inplace and to prevent rotation of the distal assembly 14 relative to thedelivery device. In some embodiments, if desired, the side-saddled lumenattachment element 120 (or 120 a) may be secured to the distal assembly14. The suture may be passed through the needle 16, and fed back towardsthe user interface. The device 10 may be extended through the body tothe defect site.

FIG. 13 is a perspective view of a distal assembly 14 c that may, forexample, be usable in the suture device 10 shown in FIG. 1. The distalassembly 14 c is similar to the distal assembly 14 shown in previousFigures, but includes several modifications that may be useful,particularly in bariatric revision procedures. A bariatric procedurecommonly refers to a procedure in which the effective useful volume of apatient's stomach may be surgically reduced in order to effect long-termweight loss for the patient and may be performed laparoscopically. Abariatric revision procedure is a procedure, performed endoscopically,in which changes may be made to what was originally done to thepatient's stomach. In some embodiments, the distal assembly 14 c mayalso be used in other suturing procedures, such as but not limited tofull tissue thickness repairs and/or partial tissue thickness repairs.

The distal assembly 14 c may include a body 29 a having a proximalconnector 30 a that may be configured to be coupled to the distal end ofan endoscope or other delivery system, for example. In some embodiments,as illustrated, the proximal connector 30 a may include a fixationfeature such as a fixation flange 401. The body 29 a includes an arm 32a that extends to an endcap 34 a. In some embodiments, the body 29 a,including the arm 32 a, may be similar to the body 29 and arm 32referenced previously with respect to the distal assembly 14, the distalassembly 14 a and the distal assembly 14 b. In some instances, however,the body 29 a and the arm 32 a may be adapted to accommodate thickertissue, which may for example mean a change in the overall shape of thebody 29 a and/or the arm 32 a relative to the body 29 and/or the arm 32.In some embodiments, the body 29 a and/or the arm 32 a may simply belarger in order to accommodate thicker tissue. The distal assembly 14 cmay be considered as including a guide member 36 a that may be securedto or integrally formed with the body 29 a, and may be configured topermit a suture translation assembly (such as the suture translationassembly 12, a suture translation assembly 12 a, shown in FIG. 14through FIG. 18, or a suture translation assembly 12 b, shown in FIG. 19through FIG. 22) to extend through the guide member 36 a and totranslate relative to the guide member 36 a.

In some embodiments, as illustrated, the guide member 36 a includes achannel 300. In some embodiments, the channel 300 permits a suture topass between the suture translation assembly 12, 12 a, 12 b and aworking channel of the endoscope or other delivery device to which thedistal assembly 14 c is attached. The channel 300 may, for example, bedesigned to include a lead in that would help to align the suture withthe channel 300 when passing the suture translation assembly 12, 12 a,12 b through the working channel of the endoscope or other deliverydevice. In some embodiments, there may be a desire to load the suturebefore passing the suture translation assembly 12, 12 a, 12 b throughthe working channel of the endoscope or other delivery device.

In some instances, the distal assembly 14 c includes a guide structure27 a that is attached to or integrally formed with the body 29 a. Insome embodiments, the guide structure 27 a may instead be pivotablyattached to the body 29 a. The guide structure 27 a may be configured toaccommodate a polymeric tubular member attached thereof, in order toguide tools through the endoscope and into position relative to theworking site. In some instances, the guide structure 27 a may beconfigured to accommodate a metallic tubular member attached thereto. Insome embodiments, for example, the guide structure 27 a and accompanyingtubular member (not illustrated) may accommodate a graspers or similartool that allows a user to grasp tissue and pull it into position sothat the needle 16 may be passed through the tissue. In someembodiments, the relative position, or offset of the guide structure 27a, relative to the relative position or offset illustrated with respectto the distal assembly 14, the distal assembly 14 a or the distalassembly 14 b, may be greater in order to provide more room for toolsand/or to accommodate larger and/or thicker portions of tissue.

The end cap 34 a includes one or more securement openings 40 a that maybe, as can be seen, be arranged orthogonally to a proximal needleopening (not illustrated), such as the proximal needle opening 37illustrated for example in FIG. 3. One or more securements 42 a maycorrespondingly be disposed within the one or more securement openings40 a. In some embodiments, the one or more securements 42 a may be acoil spring that is disposed within the one or more securement openings40 a. The securement 42 a may releasably engage a detent on the needle16, as discussed with respect to the distal assembly 14.

In some embodiments, the securement opening 40 a visible on one side (inthe illustrated orientation) may have a diameter that is greater than anoverall diameter of the securement 42 a and the securement opening 40 amay taper to a diameter on the opposite side (not seen) that is aboutthe same as the diameter of the securement 42 a. In some embodiments,the securement 42 a may be welded, soldered, adhesively secured orotherwise attached at the left side of the securement opening 40 a, andmay be free to move somewhat at the right side of the securement opening40 a. In some instances, the distal assembly 14 c may include an opening302 that is orthogonal to the securement opening 40 a. The opening 302may be threaded in order to threadedly engage a set screw 304. In someembodiments, as illustrated, the opening 302 may be offset closer to theright side of the securement opening 40 a, away from the secured end ofthe securement 42 a, such that the set screw 304 may be considered assupporting the free end of the securement 42 a. Rotating the set screw304 in a first direction, such as clockwise, may cause the set screw 304to translate towards the securement 42 a, thereby increasing aninterference between the securement 42 a and the needle 16 andincreasing a retentive force that can be applied to the needle 16.Conversely, rotating the set screw in a second direction, such ascounter-clockwise, may cause the set screw 304 to translate away fromthe securement 42 a, thereby decreasing the retentive force that can beapplied to the needle 16. This may help to adjust for manufacturingtolerances, for example.

As noted, the distal assembly 14 c may be used in combination with thesuture translation assembly 12 discussed previously with respect to FIG.5, for example. The distal assembly 14 c may also be used with a suturetranslation assembly 12 a, shown in FIG. 14 through FIG. 18, as well aswith a suture translation assembly 12 b, shown in FIG. 19 through FIG.22. FIG. 14 is a perspective view of the suture translation assembly 12a, shown holding the needle 16, while FIG. 15 is a partially explodedview of the suture translation assembly 12 a. As better seen in FIG. 15,the suture translation assembly 12 a includes an inner member 310 thathold the needle 16. A locking member 312 is slidingly disposed over theinner member 310. As can be seen, the inner member 310 includes a pin314 that extends radially outwardly from the inner member 310 andextends through a corresponding slot 316 that is formed in the lockingmember 312. The pin 314 serves to prevent relative rotation between theinner member 310 and the locking member 312. The pin 314 also serves tolimit translation of the locking member 312 relative to the inner member310.

A control member 318 is secured relative to a proximal end 320 of thelocking member 312, and extends distally to a handle such as thetranslating handle 26 (FIG. 1). As a result, the locking member 312 maybe translated distally and/or proximally relative to the inner member310. As seen in FIG. 14, the suture translation assembly 12 a includesan outer sleeve 330 that may be pinned via the pin 314 to the innermember 310. The outer sleeve 330 may be coupled with a coil 332, forexample. In some embodiments, the outer sleeve 330 may be a singletubular member. In some embodiments, as shown for example in FIG. 15,the outer sleeve 330 may actually include one or more of an outer sleeve334, a slotted sleeve 336, and an inner outer sleeve 338. The slottedsleeve 336 may be configured to permit a suture to pass therethrough.This is merely illustrative, and is not intended to be limiting in anyfashion.

The inner member 310 includes several arms 322 that, as seen in FIG. 16,which shows the distal portion of the inner member 310, include curvedtabs 324 that are configured to engage corresponding detents within theneedle 16. While a total of four arms 322 are shown, it will beappreciated that the inner member 310 may include any number of arms322. It will be appreciated that the arms 322 are relatively long inlength, and as a result may be considered as being relatively flexible.With the locking member 312 extended distally into a lockingconfiguration, as shown for example in FIG. 17, the locking member 312prevents outward movement of the arms 322. As a result, the curved tabs324 remain in engagement with the corresponding detents of the needle16, and the needle 16 remains locked to the suture translation assembly12 a. With the locking member 312 retracted proximally into an unlockedconfiguration, as shown for example in FIG. 18, the arms 322 are free tomove radially outwardly, thereby releasing the curved tabs 324 from thedetents in the needle 16, and allowing the needle 16 to move distallyrelative to the inner member 310.

FIG. 19 is a perspective view of a suture translation assembly 12 b thatmay be used in combination with any of the distal assembly 14, thedistal assembly 14 a, the distal assembly 14 b and/or the distalassembly 14 c. FIG. 20 is a perspective view of the suture translationassembly 12 b with outer portions such as an outer sleeve 350 (FIG. 19)removed to reveal an inner member 340 that holds a needle 16 a. In someembodiments, the outer sleeve 350 may be a single tubular member. Insome instances, the outer sleeve 350 may include several elements, suchas described with respect to the outer sleeve 330 (FIG. 15).

In some embodiments, as illustrated, the needle 16 a has a distal detent342 and a proximal detent 344 (visible in FIG. 21) that are shapeddifferently than the corresponding detents in the needle 16. The suturetranslation assembly 12 b includes a locking member 346 that isslidingly disposable relative to the inner member 340. The pin 352 isattached to the inner member 340 and extends through a correspondingslot 354 formed in the locking member 342. The pin 352 limitstranslation of the locking member 342 relative to the inner member 340,and also prevents relative rotational movement of the locking member342. The locking member 342 is secured to the control member 318, whichextends distally to a handle such as the translating handle 26 (FIG. 1).As a result, the locking member 342 may be translated distally and/orproximally relative to the inner member 340.

In some embodiments, the outer sleeve 350 may define a slot 370including an axially extending slot portion 372 and a shorter radiallyextending slot portion 374. In some embodiments, the axially extendingslot portion 372 permits the pin 352 to move within the axiallyextending slot portion 372 in order to permit the needle 16 a to befully withdrawn into the suture translation assembly 12 b foradvancement through an endoscope or other delivery device. Once thesuture translation assembly 12 b has been advanced through the endoscopeor other delivery device, the inner member 340 and the locking member342 may be advanced distally through the outer sleeve 350 until the pin352 aligns with the radially extending slot portion 374. By rotating thetranslating handle 26, the pin 352 may be rotated into position withinthe radially extending slot portion 374 so that the locking member 342may be translated relative to the inner member 340.

In some embodiments, as illustrated, the locking member 342 includes apair of arms 358 that extend distally from the locking member 342. Asseen for example in FIG. 21, the arms 358 include tabs 360 that, whenthe suture translation assembly 12 b is in a locked configuration asshown in FIGS. 20 and 21, the tabs 360 extend through slots 362 formedwithin the inner member 340. As a result, the tabs 360 are able toextend through the slots 362 and engage the proximal detent 344 of theneedle 16 a. While a pair of arms 358 are illustrated, it will beappreciated that the locking member 342 may include any number of arms358, and of course a corresponding number of slots 362.

In order to move the suture translation assembly 12 b into an unlockedconfiguration, as shown for example in FIG. 22, the locking member 342may be moved distally relative to the inner member 340. As can be seenin FIG. 22, the tabs 360 have moved out of the slots 362 (only one slot362 is seen), and the needle 16 a is free to move relative to the suturetranslation assembly 12 b. As the locking member 342 moves distally,angled surfaces 364 push against the slots 362 and are moved outwardly.

In some embodiments, and with respect to FIG. 13, the guide member 36 aincludes a channel 300 that is configured to permit a suture to passbetween the suture translation assembly 12, 12 a, 12 b and a workingchannel of the endoscope or other delivery device to which the distalassembly 14 c is attached. The channel 300 may, for example, be designedto include a lead in that would help to align the suture with thechannel 300 when passing the suture translation assembly 12, 12 a, 12 bthrough the working channel of the endoscope or other delivery device.In some embodiments, there may be a desire to load the suture beforepassing the suture translation assembly 12, 12 a, 12 b through theworking channel of the endoscope or other delivery device.

In some instances, as shown for example in FIG. 23, instead of putting achannel 300 in the guide member 36 a, the suture translation assembly12, 12 a, 12 b may be modified to accommodate a suture passing along thesuture translation assembly 12, 12 a, 12 b. FIG. 24 is a perspectiveview of a sleeve 20 a that may be used in forming a part of the suturetranslation assembly 12, 12 a, 12 b. It can be seen that the sleeve 20 aincludes a groove 20 b that extends a length of the sleeve 20 a. FIG. 24shows the sleeve 20 a extending through the guide member 36 a, with asuture 299 extending through the groove 20 b.

In some embodiments, movement of the suture translation assembly 12, 12a, 12 b relative to the distal assembly 14, 14 a, 14 b, 14 c,particularly as the needle 16, 16 a is passed back and forth between thesuture translation assembly 12, 12 a, 12 b and the distal assembly 14,14 a, 14 b, 14 c, may potentially interfere with securement of thedistal assembly 14, 14 a, 14 b, 14 c relative to the endoscope or otherdelivery system. FIG. 25 is a perspective view of the distal assembly 14c coupled to a split ring attachment mechanism 403 and FIG. 26 is across-sectional view thereof, taken along line 26-26 of FIG. 25. FIG. 27is a perspective view of the split ring attachment mechanism 403. Insome embodiments, and as will be discussed in greater detail, the splitring attachment mechanism 403 may be considered as including anendoscope engaging portion 405 that is adapted to engage an endoscope ina compressive fit and a distal endcap engaging portion 407 that isadapted to engage the distal endcap, or distal assembly 14 c, in aninterference fit. It will be appreciated that the split ring attachmentmechanism 403 may be used in combination with any of the distalassemblies 14, 14 a, 14 b, 14 c. While discussed and illustrated withrespect to use with the suture device 10, it will be appreciated thatthe split ring attachment mechanism 403 may be used in combination withother devices that one may wish to releasably secure to an endoscope orother delivery system.

In some embodiments, the split ring attachment mechanism 403 may beconsidered as including an elongate body 409 that largely defines theendoscope engaging portion 405. In some embodiments, as seen for examplein FIGS. 26 and 27, the elongate body 409 includes an inner surface 411that may be considered as being adapted to frictionally engage an outersurface of an endoscope to which the split ring attachment mechanism 403is being secured. In some embodiments, the elongate body 409 may have alength that is selected to provide a maximum amount of surface area forthe inner surface 411 while not interfering with the flexibility of theendoscope or other delivery system. The overall dimensions of theelongate body 409 may vary, depending on particulars of the endoscope towhich it will be attached, but in some embodiments the elongate body 409may have an overall length that is in a range of about 0.4 inches toabout 1.2 inches and a diameter that is in a range of about 0.3 inchesto about 0.6 inches. These are just examples.

While the inner surface 411 is shown as having a largely cylindricalprofile, for being secured to an endoscope having a largely cylindricalouter surface, it will be appreciated that in some embodiments theelongate body 409 and/or the inner surface 411 thereof may have adifferent profile that is complementary to an endoscope having anon-cylindrical outer surface, for example.

In some embodiments, the split ring attachment mechanism 403 may includean annular slot 413 that is complementary in position and dimension inorder to accommodate the fixation feature or flange 401 that forms partof the proximal connector 30. As can be seen in FIG. 26, when the splitring attachment mechanism 403 is in its locked configuration (asillustrated), the fixation feature or flange 401 fits into the annularslot 413 and limits relative axial movement of the distal assembly 14 crelative to the split ring attachment mechanism 403 and thus limitsrelative axial movement of the distal assembly 14 c relative to theendoscope or other delivery system to which the split ring attachmentmechanism 403 and the distal assembly 14 c are secured. As alluded to,the split ring attachment mechanism 403 may be considered as beingmovable between a locked configuration in which the split ringattachment mechanism 403 is locked to the distal assembly 14 c and anengagement configuration that enables the split ring attachmentmechanism 403 to be advanced radially over an endoscope and a distalassembly such as the distal assembly 14 c already attached to theendoscope. In some embodiments, the split ring attachment mechanism 403may be separately secured to the distal assembly 14 c, and thecombination may be axially advanced over a distal end of the endoscopeor other delivery system.

FIG. 28 is a cross-sectional view of a proximal portion of the splitring attachment mechanism 403 illustrating the locked configurationwhile FIG. 29 is a similar view illustrating the engagementconfiguration. In FIG. 28, the elongate body 409 may be seen as having afirst body portion or clamping portion 420 and a second body portion orclamping portion 422. A living hinge 424 enables the first clampingportion 420 and the second clamping portion 422 to move from the lockedconfiguration shown in FIG. 28 to the engagement configuration shown inFIG. 29. It will be appreciated that in the engagement configuration,the split ring attachment mechanism 403 may be radially advanced over anendoscope and a distal assembly secured to the endoscope. In someembodiments, as shown for example in FIG. 28, that the first clampingportion 420 and the second clamping portion 422 extend along a circle Cwhen in the locking configuration as shown. In FIG. 29, it can be seenthat the first clamping portion 420 and the second clamping portion 422are deflected away from the locking configuration, and are deflectedoutwardly away from the circle C.

In some embodiments, as shown, the living hinge 424 may simply be athinner portion of the elongate body 409 that provides additionalflexibility relative to the rest of the elongate body 409. In someembodiments, the living hinge 424 may be considered as extendinglongitudinally along the elongate body 409, as shown in FIG. 27, wherethe living hinge 424 may be seen as extending from a proximal end 426 ofthe split ring attachment mechanism 403 to a distal end 428 of the splitring attachment mechanism 403. In some instances, a mechanical hinge inwhich the first clamping portion 420 and the second clamping portion 422come together in a pivoting fashion may be used in place of the livinghinge 424.

As will be appreciated, once the split ring attachment mechanism 403 hasbeen opened up, as shown in FIG. 29, and advanced radially over theendoscope and the distal assembly 14 c disposed thereon, the split ringattachment mechanism 403 may be moved back into the lockingconfiguration shown in FIG. 28. In some instances, while notillustrated, any variety of fastening mechanisms may be used to hold thesplit ring attachment mechanism 403 into the locking configuration. Forexample, a ratcheting mechanism may be used. In some embodiments, asshown, the split ring attachment mechanism 403 may be configured toaccommodate one or more elastic members, such as but not limited toO-rings or rubber bands, to hold the split ring attachment mechanism 403in the locking configuration but also to provide a compressive forcesuch that the inner surface 411 frictionally engages the outer surfaceof the endoscope or other delivery system. In order to accommodate oneor more elastic members, the split ring attachment mechanism 403 mayinclude hooks.

As illustrated in FIG. 27, the split ring attachment mechanism 403includes a first pair of opposing hooks 430 and 432 as well as a secondpair of opposing hooks 434 and 436. In other cases, the split ringattachment mechanism 403 may only have a single pair of hooks, or mayhave two, three or more pairs of hooks. The hook 430 extends from thefirst clamping portion 420 while the hook 432 extends from the secondclamping portion 422. It will be appreciated that an elastic member (notshown in FIG. 27) may engage the hook 430, extend radially around thesplit ring attachment mechanism 403 opposite the living hinge 424, andengage the hook 432. Similarly, another elastic member may engage thehook 434, which also extends from the first clamping portion 420, extendradially around the split ring attachment mechanism 403 opposite theliving hinge 424.

In some embodiments, as shown in FIG. 27, the split ring attachmentmechanism 403 may be configured to accommodate the elastic members. Forexample, the split ring attachment mechanism 403 may include annulargrooves 440 and 442 in order to accommodate an elastic member extendingbetween the hook 430 and the hook 432. Similarly, the split ringattachment mechanism 403 may include annular grooves 444 and 446 inorder to accommodate an elastic member extending between the hook 434and the hook 436. It will be appreciated that in some embodiments, theannular grooves 440, 442 and 444, 446 may help keep the elastic membersfrom migrating axially relative to the split ring attachment mechanism403. In some embodiments, the annular grooves 440, 442 and 444, 446 alsohelp to minimize a diameter increase otherwise caused by the elasticmembers extending around the split ring attachment mechanism 403.

In some embodiments, as seen for example in FIGS. 28 and 29, the hooks430, 432, 434, 436 may be configured to provide a frictional engagementwith the elastic members. As can be seen, for example, each of the hooks430, 432 and 434, 436 include a recess 450 configured to accommodate adiameter of an elastic member and an opening 452 to the recess 450 thatis smaller than a diameter of the recess 450. This helps to hold theelastic members in place relative to the hooks 430, 432 and 434, 436.The recess 450 and the opening 452 are not labeled on FIG. 27 due to theorientation of the drawing, but are clearly visible.

FIG. 30 is a perspective view of an assembly 460 that includes thedistal assembly 14 c secured to the end of an endoscope 462 via thesplit ring attachment mechanism 403. The assembly 460 includes a firstelastic member 470 that extends from the hook 430 to the hook 432 and asecond elastic member 472 that extends from the hook 434 to the hook436. As a result of the first elastic member 470 and the second elasticmember 472, the split ring attachment mechanism 403 is able to provide acompressive force against the outer surface of the endoscope 462, andthus the inner surface 411 of the split ring attachment mechanism 403 isable to provide a frictional force against the outer surface of theendoscope 462 that helps to anchor the split ring attachment mechanism403 in place.

FIG. 31 is a perspective view of a split ring attachment mechanism 403 athat is similar to the split ring attachment mechanism 403, but includesa clip 500 that may help to hold and/or secure an external lumen orworking channel. In some embodiments, the clip 500 includes anengagement feature 502 that is configured to releasably secure anexternal lumen or working channel (not illustrated) in a snap fit. Insome instances, as shown, the clip 500 also includes a body portion 504that spaces the engagement feature 502 away from the split ringattachment mechanism 403 a. While the clip 500 is illustrated asspanning the living hinge 423, in some embodiments the clip 500 may beradially offset from the illustrated position.

FIG. 32 is a perspective view of a split ring attachment mechanism 403 band FIG. 33 is a cross-sectional view of the split ring attachmentmechanism 403 b. The split ring attachment mechanism 403 b includes anelongate body 409 a that is divided into a first clamping portion 420 aand a second clamping portion 422 a by an elongate living hinge 424 a. Ahook 434 a extends from the first clamping portion 420 a and acorresponding hook 436 a extends from the second clamping portion 422 a.The split ring attachment mechanism 403 b includes an elongate body 409a that defines the annular slot 413 as well as a pair of annular grooves444 a and 446 a that are configured to accommodate an O-ring or otherelastic member to secure the split ring attachment 403 b in its lockingconfiguration (as shown) by extending around the elongate body 409 afrom the hook 434 a to the hook 436 a.

It can be seen that the first clamping portion 420 a is relativelysmaller than the second clamping portion 422 a, as the elongate livinghinge 424 a is offset relative to a position of the living hinge 424 asseen in FIG. 27 or FIG. 31, for example. In some embodiments, the firstclamping portion 420 a and the second clamping portion 422 a may, incomparison to the first clamping portion 420 and the second clampingportion 422 (seen in FIGS. 27 and 31, for example) may not extendcircumferentially about the endoscope as far as the first clampingportion 420 and the second clamping portion 422. In some embodiments,having the elongate living hinge 424 a be offset better facilitatesplacing the first clamping portion 420 a and the second clamping portion422 a about the endoscope or other delivery system. In some embodiments,offsetting the elongate living hinge 424 a relative to the clip 500means that the clip 500 does not potentially impact the flexibility ofthe elongate living hinge 424 a.

The split ring attachment mechanism 403, 403 a, 403 b may be made of anysuitable material. In some embodiments, the split ring attachmentmechanism 403, 403 a, 403 b may be made of a polymer such as but notlimited to PEEK (polyetheretherketone), ABS (acrylonitrile butadienestyrene), polycarbonate, rubber, silicone, thermoplastic elastomers suchas but not limited to PEBA (polyether block amide), available under thePEBAX® name, SLA and others.

FIGS. 25 through 33 illustrate a split ring attachment mechanism 403,403 a that may be used to releasably secure the distal endcap 14, 14 a,14 b, 14 c to the distal end of the endoscope 462. It will beappreciated that other attachment mechanisms may also be used. FIGS. 34through 52 provide illustrative but non-limiting examples of attachmentmechanisms that are disposable over an exterior of the endoscope 462proximate a distal end thereof in order to releasably secure the distalendcap relative to the distal end of the endoscope 462. In someembodiments, for example, a suitable attachment mechanism may include aninner collet member 600 as shown in FIG. 34 that is configured to engagethe distal endcap 14, 14 a, 14 b, 14 c and form a compressive fit withthe endoscope 462. A suitable attachment mechanism may also include anouter collet member 602 as shown in FIG. 35 that is configured to engagethe inner collet member 600 in order to form the compressive fit betweenthe inner collet member 600 and the endoscope 462.

As seen in FIG. 34, the inner collet member 600 includes an annular ringportion 604. In some embodiments, the annular ring 604 defines orotherwise includes an annular groove 612 that is configured toaccommodate the fixation feature 401 present on the distal endcap 14, 14a, 14 b, 14 c. The fixation feature 401 is visible, for example, inFIG. 1. It will be appreciated that the interaction between the annulargroove 612 and the fixation feature 401 may secure the inner colletmember 600 to the distal endcap 14, 14 a, 14 b, 14 c. The inner colletmember 600 includes a number of fingers 606 that are adapted to interactwith an outer surface of the endoscope 462 to provide a compressive fitbetween the inner collet member 600 and the endoscope 462. In someembodiments, the fingers 606 may be considered as extending axially fromthe annular ring 604 in a proximal direction. As illustrated, the innercollet member 600 includes a total of four fingers 606 a, 606 b, 606 cand 606 d. In some embodiments, the inner collet member 600 may havemore than four fingers 606, or may have fewer than four fingers 606.

In some embodiments, as shown, the fingers 606 each include a threadedportion 608 that corresponds to threading on the outer collet member602. The inner collet member 600 includes slots 610 disposed betweenadjacent fingers 606 such that the fingers 606 can bend inwardly as theouter collet member 602 is threaded over the inner collet member 600. Itwill be appreciated that the fingers 606 collectively define an innersurface 614 of the inner collet member 600. FIGS. 36 and 37 areschematic cross-sections of the inner collet member 600. In FIG. 36, theinner surface 614 may be seen as defining a constant diameter cylinderwhile in FIG. 37, the inner surface 614 is divided in to a first section614 a and a second section 614 b, where the second section 614 b definesa reduced-diameter cylinder relative to that defined by the firstsection 614 a. In some embodiments, having a reduced-diameter portionhelps with securing to a relatively smaller diameter endoscope 462, forexample, and in some embodiments can lead to an increased surfacecontact area between the inner collet member 600 and the endoscope 462.

Returning briefly to FIG. 35, the outer collet member 602 includes anouter knurled surface 620 that facilitates grasping and turning theouter collet member 602 relative to the inner collet member 600. Theouter collet member 602 also includes a threaded inner surface 622 thatengages the threaded portions 608 of each of the fingers 606 of theinner collet member 600. FIGS. 38 and 39 illustrate the inner colletmember 600 and the outer collet member 602 in a detached and attachedconfiguration, respectively, with an endoscope 462. The inner colletmember 600 and the outer collet member 602 may secure a distal endcapsuch as the distal endcap 14 c to the endoscope 462.

As can be seen in FIG. 38, the inner collet member 600 is positioned inengagement with the distal endcap 14 c. While not visible, the fixationfeature 401 may be engaged within the annular groove 612 to secure theinner collet member 600 to the distal endcap 14 c. In some embodiments,the distal endcap 14 may be attachable to the endoscope 462 via thecollet members 600, 602 by any configuration, e.g., tongue and groove,pins, and the like, so that the distal endcap 14 is secured to theendoscope 462 for performing a medical procedure. The outer colletmember 602 is seen disposed over the endoscope 462. By moving the outercollet member 602 in a direction indicated by an arrow 630, the outercollet member 602 engages the inner collet member 600. Rotating theouter collet member 602 causes the outer collet member 602 to threadedlyengage the inner collet member 600. As the outer collet member 602continues to translate in the direction indicated by the arrow 630, theouter collet member 602 forces the fingers 606 into a compressive fitwith the endoscope 462. FIG. 39 shows the distal endcap 14 c secured tothe endoscope 462 via the interaction between the inner collet member600 and the outer collet member 602.

FIG. 40 shows an inner collet member 600 a that is integrally formedwith a distal endcap 14 d. Operation is otherwise the same as thatdescribed with respect to FIGS. 38 and 39. In some embodiments, theinner collet member 600 a may be integrally molded as part of the distalendcap 14 d. In some instances, the inner collet member 600 a may beadhesively secured to the distal endcap 14 d. The inner collet member600 a may be separately formed, and then snap fit onto the distal endcap14 d. These are just examples.

FIGS. 41 and 42 show a distal endcap 14 e that includes a number ofproximally extending fingers 640. A ring 642 may be moved proximally, ina direction indicated by an arrow 644. As the ring 642 is movedproximally, the ring 642 compresses the proximally extending fingers 640into a compressive fit with the endoscope 462. In some embodiments, thering 642 may be a rigid ring. In some instances, the ring 642 may beelastomeric, and thus can stretch as the ring 642 is advanced proximallyover the fingers 640, and thus can provide a compressive force on thefingers 640. FIG. 42 shows the distal endcap 14 e secured to theendoscope 462.

FIG. 43 is a perspective view of an attachment mechanism 650 that insome ways is similar to the split ring attachment mechanism 403described with respect to previous Figures. The attachment mechanism 650includes a body 652 that is curved to fit part way around an endoscopesuch as the endoscope 462. The attachment mechanism 650 includes anannular ring portion 654 that extends radially around a greater distancethan the body 652. While not visible, in some embodiments, the annularring portion 654 includes a groove similar to the annular groove 612that is configured to engage the fixation feature 401 of distal endcap14, 14 a, 14 b, 14 c. The attachment mechanism 650 includes hooks 656and 658 extending radially outwardly from the body 652. The hooks 656and 658 may accommodate an elastomeric member extending from the hook656, around the endoscope 462 and to the hook 658.

FIG. 44 is a perspective view of a distal endcap 14 f secured to theendoscope 462. The distal endcap 14 f includes a fixation member 660extending radially outwardly from the distal endcap 14 f. The fixationmember 660 may be integrally formed with the distal endcap 14 f, forexample, or may be adhesively secured to the distal endcap 14 f. Anelastomeric sleeve 662 may be configured to be stretched over theendoscope 462 to provide a compressive fit between the elastomericsleeve 662 and the endoscope 462. In some embodiments, as shown, theelastomeric sleeve 662 includes a fixation aperture 664 thataccommodates the fixation member 660 extending therethrough. It will beappreciated that the fixation member 660 and the fixation aperture 664together provide an interference fit. While the fixation member 660 andthe fixation aperture 664 are both illustrated as having a rectilinearshape, this is merely illustrative, as the fixation member 660 and thefixation aperture 664 may take any desired shape. In some embodiments,the distal endcap 14 f may include two or more fixation members 660 andthe elastomeric sleeve 662 may include two or more correspondingfixation apertures 664.

FIG. 45 is a perspective view of an attachment mechanism 670 securingthe distal endcap 14 c to the endoscope 462. The attachment mechanism670 is similar to the split ring attachment mechanism 403, 403 a andincludes a body 672. The body 672 defines annular grooves 674 and 676for accepting snap rings 678 and 680, respectively. The snap rings 678,680 are flexible enough to open sufficiently to fit over the body 672and into the annular grooves 674, 676, respectively, and then reclose toprovide a compressive force on the body 672 to close a gap 673 and thusprovide a compressive fit between the attachment mechanism 670 and theendoscope 462. While not illustrated, the attachment mechanism 670 mayhave an interference fit with the endoscope 462.

FIGS. 46 and 47 illustrate an attachment mechanism 690. The attachmentmechanism 690 includes a number of hook members 692 that can be securedto the endoscope 462. Each of the hook members 692 includes a hook end694 that is configured to fit into corresponding slots 696 that areformed in a distal endcap 14 g. With a ring 698 positioned as shown inFIG. 46, the hook members 692 are free to rotate as indicated by arrows697. As a result, the hook ends 694 can be inserted into the slots 696.By moving the ring 698 distally in a direction indicated by an arrow699, the ring 698 prevents the hook ends 694 from backing out of theslots 696, thereby securing to the distal endcap 14 g.

FIG. 48 is a side view of an attachment mechanism 700 that includes amounting feature 702 extending proximally from a distal endcap 14 h andan adaptor 704 that is configured to be secured to the endoscope 462.The adaptor 704 includes radially extending pegs 706 that fit intocorresponding holes 708 that are formed in the mounting feature 702. Insome embodiments, this may be reversed, with the holes 708 formed in theadaptor 704 and the pegs 706 formed on the mounting feature 702.

FIG. 49 is a side view of an attachment mechanism 710 that includes amounting feature 712 extending proximally from a distal endcap 14 i andan adaptor 714 that is configured to be secured to the endoscope 462.The adaptor 714 includes axially extending pegs 716 that fit intocorresponding holes 718 that are formed in the mounting feature 712. Insome embodiments, this may be reversed, with the holes 718 formed in theadaptor 714 and the pegs 716 formed on the mounting feature 712.

FIG. 50 is a side view of an attachment mechanism 720 that may be usedfor securing a distal endcap to the endoscope 462. The attachmentmechanism 720 has a body 722 that is configured to fit around theendoscope 462 and a distal endcap (not shown). As can be seen, the body722 defines a slot 724 that facilitates placement of the attachmentmechanism 720. Once placed, a pair of zip ties 726 may be used tocompress the attachment mechanism 720 onto the endoscope, narrowing theslot 724.

FIG. 51 is a side view of an attachment mechanism 730 that may be usedfor securing a distal endcap to the endoscope 462. In simple terms, theattachment mechanism 730 may be considered as an example of a Chinesefinger trap. The attachment mechanism 730 is a cylindrical, helicallywound braid. Shortening the attachment mechanism 730 in an axialdirection causes the attachment mechanism 730 to expand radially. Inthis configuration, the attachment mechanism 730 may be disposed over anendoscope and a distal endcap. Stretching the attachment mechanism 730axially causes the attachment mechanism 730 to compress radially, whichcan secure the attachment mechanism 730 to both the endoscope 462 andthe distal endcap. It will be appreciated that any further axialstretching, as would occur if the distal endcap moves away from theendoscope 462 during use, would further compress the attachmentmechanism 462 radially.

FIG. 53 is a side view of a distal endcap 14 j secured relative to theendoscope 462. The distal endcap 14 j includes a fixation feature 682that interacts with a sleeve 680 that is disposed over the endoscope462. The sleeve 680 and the fixation feature 682 together provide abearing ball quick-release feature similar to that used in connectingpressurized air hoses, for example.

It will be appreciated that a variety of different materials may be usedin forming the devices described herein. In some embodiments, a varietyof different metals may be used. Illustrative but non-limiting examplesof suitable metals include titanium, stainless steel, magnesium, cobaltchromium and others. In some embodiments, for example, the devicesdescribed herein may include any suitable polymeric material, includingbiocompatible materials such as polyurethane or silicone. Other suitablepolymers include but are not limited to polytetrafluoroethylene (PTFE),ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene(FEP), polyoxymethylene (POM, for example, DELRIN® available fromDuPont), polyether block ester, polyurethane (for example, Polyurethane85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (forexample, ARNITEL® available from DSM Engineering Plastics), ether orester based copolymers (for example, butylene/poly(alkylene ether)phthalate and/or other polyester elastomers such as HYTREL® availablefrom DuPont), polyamide (for example, DURETHAN® available from Bayer orCRISTAMID® available from Elf Atochem), elastomeric polyamides, blockpolyamide/ethers, polyether block amide (PEBA, for example availableunder the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA),silicones, polyethylene (PE), Marlex high-density polyethylene, Marlexlow-density polyethylene, linear low density polyethylene (for exampleREXELL®), polyester, polybutylene terephthalate (PBT), polyethyleneterephthalate (PET), polytrimethylene terephthalate, polyethylenenaphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI),polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide(PPO), poly paraphenylene terephthalamide (for example, KEVLAR®),polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMSAmerican Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinylalcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like.

Those skilled in the art will recognize that the present disclosure maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departure in form anddetail may be made without departing from the scope and spirit of thepresent disclosure as described in the appended claims.

What is claimed is:
 1. A suture assembly for use in combination with anendoscope having a working channel and a distal end, the suture assemblycomprising: a suturing assembly adapted to transfer a needle back andforth through tissue, the needle carrying a suture, the suturingassembly adapted to be secured relative to the distal end of theendoscope; and an attachment mechanism disposable over an exterior ofthe endoscope proximate the distal end thereof, the attachment mechanismconfigured to releasably secure the suturing assembly relative to thedistal end of the endoscope; wherein the attachment mechanism comprisesan inner collet member that is configured to engage the suturingassembly and form a compressive fit with the endoscope; and an outercollet member that is configured to engage the inner collet member inorder to form the compressive fit between the inner collet member andthe endoscope.
 2. The suture assembly of claim 1, wherein the suturingassembly further comprises an annular flange disposed at a proximal endof the suturing assembly, and the inner collet member further comprisesa corresponding annular slot disposed near a distal end of the innercollet member, the annular slot configured to engage the annular flange,thereby providing an interference fit between the suturing assembly andthe inner collet member.
 3. The suture assembly of claim 2, wherein theinner collet member includes an body having a plurality of fingersextending axially in a proximal direction from the distal end of theinner collet member, the plurality of fingers defining an inner surfacethat is configured to engage the endoscope and an outer surface thatprovides threads to threadedly engage the outer collet adaptor.
 4. Thesuture assembly of claim 3, wherein the outer collet member isconfigured to urge the plurality of fingers inwardly as the outer colletmember is advanced over the inner collet member.
 5. The suture assemblyof claim 1, wherein the inner collet member is integrally formed withthe suturing assembly.
 6. The suture assembly of claim 5, wherein theinner collet member comprises a plurality of fingers extendingproximally from the suturing assembly, and the outer collet membercomprises a ring that is configured to be moved proximally over theplurality of fingers, thereby pressing the plurality of fingers into acompressive fit with the endoscope.
 7. A suture assembly for use incombination with an endoscope having a working channel and a distal end,the suture assembly comprising: a suturing assembly adapted to transfera needle back and forth through tissue, the needle carrying a suture a,the suturing assembly including a fixation flange disposed near aproximal end of the suturing assembly; an inner collet member that isconfigured to engage the suturing assembly and form a compressive fitwith the endoscope; and an outer collet member that is configured toengage the inner collet member in order to form the compressive fitbetween the inner collet member and the endoscope.
 8. The sutureassembly of claim 7, wherein the outer collet member is threadedlyengageable with the inner collet member in order to form the compressivefit with the endoscope.
 9. The suture assembly of claim 7, wherein thesuturing assembly further comprises an annular flange disposed at aproximal end of the suturing assembly, and the inner collet memberfurther comprises a corresponding annular slot disposed near a distalend of the inner collet member, the annular slot configured to engagethe annular flange, thereby providing an interference fit between thesuturing assembly and the inner collet member.
 10. The suture assemblyof claim 7, wherein the inner collet member includes an body having aplurality of fingers extending axially in a proximal direction from thedistal end of the inner collet member, the plurality of fingers definingan inner surface that is configured to engage the endoscope and an outersurface that provides threads to threadedly engage the outer colletadaptor.
 11. The suture assembly of claim 8, wherein the outer colletmember is configured to urge the plurality of fingers inwardly as theouter collet member is advanced over the inner collet member.